Chlorothiazide And Reserpine

ANDA 88365, held by Hikma. Chlorothiazide; Reserpine.

As of Nov 15, 2026, ANDA 88365 (Chlorothiazide And Reserpine), held by Hikma, was first approved by FDA on Dec 22, 1983, with 1 approved supplement and 0 published complete response letters.

First approved: Dec 22, 1983
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Dec 22, 1983	Original application	Approved	None posted

Products

2 strengths and forms


Chlorothiazide And Reserpine500MG;0.125MG · tablet;oral	Chlorothiazide; Reserpine	Discontinued
Chlorothiazide And Reserpine250MG;0.125MG · tablet;oral	Chlorothiazide; Reserpine	Discontinued

All 2 submissions, including labeling and manufacturing supplements


May 14, 1991	Supplement 10Manufacturing	Approved	None posted
Dec 22, 1983	Original application	Approved	None posted

Identifiers

Application: ANDA 88365
Drugs@FDA: Overview at FDA
Company: Hikma

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters